Psoriasis Clinical Trial

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).

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Full Description

This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab. The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all participants will be based on their level of response. All participants will receive guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at Week 264 (open label treatment period). The end of the study is defined as the time the last participant completes the Week 264 visit. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.

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Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline
Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
Must be a candidate for either systemic therapy or phototherapy for psoriasis

Exclusion Criteria:

Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Participants who have ever received guselkumab or adalimumab
History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

992

Study ID:

NCT02207244

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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Birmingham Alabama, , United States

Bakersfield California, , United States

Los Angeles California, , United States

San Diego California, , United States

Santa Monica California, , United States

Aurora Colorado, , United States

Coral Gables Florida, , United States

Tampa Florida, , United States

Newnan Georgia, , United States

Sandy Springs Georgia, , United States

Chicago Illinois, , United States

Rolling Meadows Illinois, , United States

Skokie Illinois, , United States

Indianapolis Indiana, , United States

Plainfield Indiana, , United States

Louisville Kentucky, , United States

Andover Massachusetts, , United States

Fort Gratiot Michigan, , United States

Troy Michigan, , United States

Saint Louis Missouri, , United States

Albuquerque New Mexico, , United States

New York New York, , United States

Gahanna Ohio, , United States

Norman Oklahoma, , United States

Portland Oregon, , United States

Pittsburgh Pennsylvania, , United States

Johnston Rhode Island, , United States

Arlington Texas, , United States

Houston Texas, , United States

Salt Lake City Utah, , United States

Seattle Washington, , United States

Spokane Washington, , United States

Benowa , , Australia

Hectorville , , Australia

Melbourne , , Australia

Parkville , , Australia

Westmead , , Australia

Woolloongabba , , Australia

Barrie Ontario, , Canada

Hamilton Ontario, , Canada

Mississauga Ontario, , Canada

Ottawa Ontario, , Canada

Richmond Hill Ontario, , Canada

Toronto Ontario, , Canada

Waterloo Ontario, , Canada

Windsor Ontario, , Canada

Jihlava , , Czechia

Nachod , , Czechia

Pardubice , , Czechia

Plzen , , Czechia

Praha 10 , , Czechia

Praha 5 , , Czechia

Usti nad Labem , , Czechia

Dresden , , Germany

Gera , , Germany

Hamburg , , Germany

Kiel , , Germany

Leipzig , , Germany

Lubeck , , Germany

Munster , , Germany

Tübingen , , Germany

Witten , , Germany

Busan , , Korea, Republic of

Daejeon , , Korea, Republic of

Gwangju , , Korea, Republic of

Incheon , , Korea, Republic of

Seongnam , , Korea, Republic of

Seoul , , Korea, Republic of

Suwon , , Korea, Republic of

Bialystok , , Poland

Bydgoszcz , , Poland

Gdansk , , Poland

Krakow , , Poland

Lodz , , Poland

Lublin , , Poland

Olsztyn , , Poland

Poznan , , Poland

Poznań , , Poland

Torun , , Poland

Warszawa , , Poland

Wroclaw , , Poland

Chelyabinsk , , Russian Federation

Cherepovets , , Russian Federation

Moscow , , Russian Federation

Rostov-on-Don , , Russian Federation

Ryazan , , Russian Federation

St-Petersburg , , Russian Federation

St. Petersburg , , Russian Federation

Yaroslavl , , Russian Federation

Badalona , , Spain

Barcelona , , Spain

Bilbao Vizcaya , , Spain

Madrid , , Spain

Murcia , , Spain

Pontevedra , , Spain

Valencia , , Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

992

Study ID:

NCT02207244

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

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